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首页> 外文期刊>The journal of clinical psychiatry >A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder.
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A randomized, double-blind, placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder.

机译：阿立哌唑在最近躁狂的躁郁症I型患者中进行的一项随机，双盲，安慰剂对照的26周试验。

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OBJECTIVE: To investigate the safety and efficacy of aripiprazole in preventing relapse of a mood episode in recently manic- or mixed-episode patients with bipolar I disorder stabilized on aripiprazole. METHOD: This randomized, double-blind, parallel-group, placebo-controlled, multicenter study enrolled patients from 76 centers in 3 countries (Argentina, Mexico, United States) from March 2000 to June 2003. Bipolar I disorder (DSM-IV) patients who had recently been hospitalized and treated for a manic or mixed episode entered an open-label stabilization phase (aripiprazole monotherapy: 15 or 30 mg/day, 6-18 weeks). After meeting stabilization criteria (Young Mania Rating Scale score of < or = 10 and Montgomery-Asberg Depression Rating Scale score of < or = 13 for 6 consecutive weeks), 161 patients were randomly assigned to aripiprazole or placebo for the 26-week, double-blind phase. The primary endpoint was time to relapse for a manic, mixed, or depressive episode (defined by discontinuation caused by lack of efficacy). RESULTS: Aripiprazole was superior to placebo in delaying the time to relapse (p = .020). Aripiprazole-treated patients had significantly fewer relapses (25%) than placebo patients (43%; p = .013). Aripiprazole was superior to placebo in delaying the time to manic relapse (p = .01); however, no significant differences were observed in time to depressive relapse (p = .68). Weight gain (> or = 7% increase) occurred in 7 (13%) aripiprazole-treated and 0 placebo-treated patients. Adverse events (> or = 5% incidence and twice that of placebo) reported by aripiprazole-treated patients were akathisia, pain in the extremities, tremor, and vaginitis. CONCLUSIONS: Aripiprazole, 15 or 30 mg/day, was superior to placebo in maintaining efficacy in patients with bipolar I disorder with a recent manic or mixed episode who were stabilized and maintained on aripiprazole treatment for 6 weeks, as shown by a longer time to relapse.
机译：目的：探讨阿立哌唑预防近期躁狂或混合发作的躁郁症患者的情绪发作复发的安全性和有效性，阿立哌唑稳定。方法：这项随机，双盲，平行组，安慰剂对照的多中心研究纳入了2000年3月至2003年6月来自3个国家（阿根廷，墨西哥，美国）的76个中心的患者。双相I型障碍（DSM-IV）最近入院治疗躁狂或混合发作的患者进入开放标签稳定期（阿立哌唑单一疗法：每天15或30毫克/天，6-18周）。达到稳定标准后（连续6周，年轻躁狂症评分量表评分为<或= 10，蒙哥马利-阿斯伯格抑郁量表评分为<或= 13），将161名患者随机分配阿立哌唑或安慰剂26周，盲阶段。主要终点是躁狂，混合性或抑郁性发作的复发时间（定义为因缺乏疗效而停药）。结果：阿立哌唑在延迟复发时间方面优于安慰剂（p = .020）。阿立哌唑治疗的患者复发率（25％）显着低于安慰剂患者（43％; p = .013）。阿立哌唑在延迟躁狂复发时间方面优于安慰剂（p = 0.01）;但是，在抑郁复发的时间上没有观察到显着差异（p = 0.68）。 7例（13％）接受阿立哌唑治疗的患者和0例接受安慰剂治疗的患者发生了体重增加（>或= 7％的增加）。由阿立哌唑治疗的患者报告的不良事件（≥5％或安慰剂的2倍）是静坐不全，四肢疼痛，震颤和阴道炎。结论：每天15或30毫克的阿立哌唑在维持躁狂或混合发作的躁郁型I型双相情感障碍患者中，在维持和维持阿立哌唑治疗6周的基础上，在维持疗效方面优于安慰剂，从更长的时间可以看出复发。

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